QA Associate – Fill Finish

Key Responsibilities

• Provide Quality direction and oversight of start-up, technical transfer, operation, and improvement of Sterile Drug Product Filling operations
• Provide Quality input to Change Controls, Protocols and Reports
• Write, review and approve SOPs, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation
• Participate in inter-departmental and cross-functional project teams
• Prioritize tasks to ensure critical tasks are completed on time
• Provide Quality input and guidance for Lot Release
• Compile Lot Release Packs
• Provide Quality input to Deviations
• Review and approve Deviations and associated CAPAs
• Exercise judgment to determine appropriate action and ensure proper escalation
• Identify compliance risks and take preventative actions
• Lead root cause analysis for complex issues
• Ensure high level of Quality / cGMP Awareness
• Lead Area GMP Certification Activities
• Support pre-approval Regulatory Inspection readiness
• Support Quality Assurance elements for new product launches

Requirements

Education

Degree or 3rd level qualification (Science, Quality)

Experience

5+ years

Required Skills

• Knowledge of FDA / EMEA regulations/standards and quality systems
• Ability to work independently
• Teamwork and leadership skills
• Strong organizational skills
• Proficiency in Excel, Word, PowerPoint
• Decision making capability
• Coaching skills
• Excellent written and verbal communication
• Problem solving
• Experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
• Experience in Sterile Drug Product Filling and start-up
• Validation knowledge/experience
• MES experience
• Knowledge of Lean / Continuous Improvement practices

Required Certifications

• QP Qualification (advantage)